- Merck & Co. (Rahway, NJ)
- …and skills: Three (3) years of experience in managing regulatory submissions and document management systems such as Veeva Vault and RIMSStrong knowledge of ... related to regulatory operations.Experience in managing regulatory submissions and document management systems.Familiarity with electronic submission formats and… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionWe are currently hiring an experienced document writer to join our team in South San Francisco, CA.The nonclinical pharmacology writing group prepares ... pharmacology study reports, written summaries, and related documents, managing author/ management reviews, ensuring documents meet regulatory compliance requirements, and… more
- Aequor (Bothell, WA)
- Job Description (Required): SUMMARY: is seeking a Senior Software Developer to develop and maintain an internal R package and to develop R-based ETL scripts for ... coworkers to ensure compatibility within code base. - Test, debug and document software applications. Commit changes to git-based source version control. - Consult… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Merck & Co. (Durham, NC)
- …over the last several years; currently Durham employs 1,000+ people.Durham's Senior Technician, Operations will be an energetic leader with strong interpersonal, ... limited to;Support operations production through licensure and ramp up.Participate in document design activities working alongside operations team members to develop… more
- Modern Technology Solutions, Inc. (Fairborn, OH)
- …Own Your Future. Modern Technology Solutions, Inc. (MTSI) is seeking a Systems Engineer - Senior in Dayton, OH. The Systems Engineer - Senior is a key poistion ... and semi-annaul bonues. POSITION OVERVIEW: The Systems Engineer - Senior will provide technical support and advice in a...technical support and advice in a classified systems Program Management Office (PMO) on current and future program design,… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP system...and develop subject matter expertise- - Knowledge of order management , supply chain operations and document control… more
- Merck & Co. (Rahway, NJ)
- … Document (CTD) and label, including relevant compound/program life-cycle management .The successful candidate will have an essential strategic and tactical role ... principles of drug development to ensure compound transition along the pipeline, management experience, and importantly the ability to work with ambiguity and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... in design and geographic scope). Prepares clinical section of regulatory document . Collaborates as team member with AROs/CROs. Drafts development plans, protocol… more
- TekSynap (Fort Meade, MD)
- …Clearance: + Must Possess a TS/SCI with CI Polygraph **Overview** We are seeking a Senior Document Management Specialist to join our team supporting US ... **Responsibilities & Qualifications** **RESPONSIBILITIES** + Implement and manage enterprise-wide document management systems ensuring compliance with cybersecurity… more
